Systems, devices, and methods for providing electrical stimulation therapy feedback

ABSTRACT

A system for storing stimulation programs or sets of stimulation parameters includes at least one memory; at least one of i) multiple stimulation programs or ii) a multiple sets of stimulation parameters stored on the at least one memory from multiple different devices remote from the system and used to stimulate different patients; at least one processor coupled to the at least one memory to retrieve the stored stimulation programs or sets of stimulation parameters from the at least one memory when requested and to store additional stimulation programs or sets of stimulation parameters on the at least one memory; and a communications arrangement coupled to the at least one processor to deliver the stored stimulation programs or sets of stimulation parameters to external device and to receive additional stimulation programs and sets of stimulation parameters from external devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 14/807,466 filed Jul. 23, 2015 which claims the benefit under35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No.62/028,704 filed Jul. 24, 2014, both of which are incorporated herein byreference in their entireties.

FIELD

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationsystems include devices or methods for providing feedback regardingelectrical stimulation, as well as methods of making and using theelectrical stimulation systems.

BACKGROUND

Implantable electrical stimulation systems have proven therapeutic in avariety of diseases and disorders. For example, spinal cord stimulationsystems have been used as a therapeutic modality for the treatment ofchronic pain syndromes. Peripheral nerve stimulation has been used totreat chronic pain syndrome and incontinence, with a number of otherapplications under investigation. Functional electrical stimulationsystems have been applied to restore some functionality to paralyzedextremities in spinal cord injury patients.

Stimulators have been developed to provide therapy for a variety oftreatments. A stimulator can include an implantable pulse generator(IPG), one or more leads, and an array of stimulator electrodes on eachlead. The stimulator electrodes are in contact with or near the nerves,muscles, or other tissue to be stimulated. The pulse generator generateselectrical pulses that are delivered by the electrodes to body tissue.

BRIEF SUMMARY

One embodiment is a system for storing stimulation programs or sets ofstimulation parameters. The system includes at least one memory; atleast one of i) a plurality of stimulation programs or ii) a pluralityof sets of stimulation parameters stored on the at least one memory froma plurality of different devices remote from the system and used tostimulate a plurality of different patients; at least one processorcoupled to the at least one memory to retrieve the stored stimulationprograms or sets of stimulation parameters from the at least one memorywhen requested and to store additional stimulation programs or sets ofstimulation parameters on the at least one memory; and a communicationsarrangement coupled to the at least one processor to deliver the storedstimulation programs or sets of stimulation parameters to externaldevice and to receive additional stimulation programs and sets ofstimulation parameters from external devices.

In at least some embodiments, the system further includes lead placementinformation for at least one stimulation therapy stored on the at leastone memory and accessible via the at least one processor andcommunications arrangement.

In at least some embodiments, the system is configured and arranged, viathe at least one processor and communications arrangement, to receive ascore or rating for at least one of the stimulation programs or sets ofstimulation parameters and to store, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters. In at least someembodiments, the system is configured and arranged, via the at least oneprocessor and communications arrangement, to request the score or ratingfor at least one of the stimulation programs or sets of stimulationparameters from a user that has received the one of the stimulationprograms or sets of stimulation parameters. In at least someembodiments, the system is configured and arranged, via the at least oneprocessor and communications arrangement, to receive a review orrecommendation for at least one of the stimulation programs or sets ofstimulation parameters and to store, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters.

In at least some embodiments, the at least one processor is configuredand arranged to analyze the stimulation programs or sets of stimulationparameters and, via at least one machine learning algorithm, generate anew stimulation program or set of stimulation parameters to improvetreatment efficacy. In at least some embodiments, the at least oneprocessor is configured and arranged to analyze the stimulation programsor sets of stimulation parameters and, via at least one machine learningalgorithm, generate a modified stimulation program or set of stimulationparameters to improve treatment efficacy. In at least some embodiments,the at least one processor is configured and arranged to analyze thestimulation programs or sets of stimulation parameters and, via at leastone machine learning algorithm, generate a new stimulation program orset of stimulation parameters based on at least one of a patientcharacteristic; disease or disorder or condition; symptom or symptoms;stimulation device or lead type; or electrode or lead location.

In at least some embodiments, the system is configured and arranged topermit a user to purchase at least one of the stimulation programs orsets of stimulation parameters and to provide, via the at least oneprocessor and communications arrangement, the purchased at least one ofthe stimulation programs or sets of stimulation parameters to the user.In at least some embodiments, the system is configured and arranged tocategorize the stimulation programs or sets of stimulation parametersand to permit the user to access the stimulation programs or sets ofstimulation parameters via the categorization. In at least someembodiments, the categorization is based on at least one of type ofdisease or disorder or condition; type of stimulation; area of symptommanifestation; lead or electrode placement; or physical activity type.

Another embodiments is a computer-based method, where actions areperformed by a processor, the actions including: receiving a pluralityof stimulation programs or a plurality of sets of stimulation parametersfrom a plurality of different devices remote from the processor and usedto stimulate a plurality of different patients; storing the plurality ofstimulation programs or plurality of sets of stimulation parameters onat least one memory; and retrieve the stored stimulation programs orsets of stimulation parameters from the at least one memory whenrequested by user.

In at least some embodiments, the actions further include receiving ascore or rating for at least one of the stimulation programs or sets ofstimulation parameters and storing, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters. In at least someembodiments, the actions further include requesting the score or ratingfor at least one of the stimulation programs or sets of stimulationparameters from a user that has received the one of the stimulationprograms or sets of stimulation parameters. In at least someembodiments, the actions further include receiving a review orrecommendation for at least one of the stimulation programs or sets ofstimulation parameters and storing, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters.

In at least some embodiments, the actions further include analyzing thestimulation programs or sets of stimulation parameters and, via at leastone machine learning algorithm, generating a new stimulation program orset of stimulation parameters to improve treatment efficacy. In at leastsome embodiments, the actions further include analyzing the stimulationprograms or sets of stimulation parameters and, via at least one machinelearning algorithm, generating a modified stimulation program or set ofstimulation parameters to improve treatment efficacy. In at least someembodiments, the actions further include analyzing the stimulationprograms or sets of stimulation parameters and, via at least one machinelearning algorithm, generating a new stimulation program or set ofstimulation parameters based on at least one of a patientcharacteristic; disease or disorder or condition; symptom or symptoms;stimulation device or lead type; or electrode or lead location.

In at least some embodiments, the actions further include permitting auser to purchase at least one of the stimulation programs or sets ofstimulation parameters and providing the purchased at least one of thestimulation programs or sets of stimulation parameters to the user. Inat least some embodiments, the actions further include categorizing thestimulation programs or sets of stimulation parameters and to permit theuser to access the stimulation programs or sets of stimulationparameters via the categorization.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic block diagram of one embodiment of an electricalstimulation system, according to the invention;

FIG. 2 is a schematic block diagram of another embodiment of anelectrical stimulation system, according to the invention;

FIG. 3A is a schematic block diagram of another embodiment of anelectrical stimulation system, according to the invention;

FIG. 3B is a schematic block diagram of an arrangement in which multipledevices can access a database (or store) for uploading and downloadingstimulation programs, sets of stimulation parameter, or otherinformation, according to the invention;

FIG. 4 is a schematic block diagram of one embodiment of a patientinterface unit, according to the invention;

FIG. 5 is a schematic block diagram of one embodiment of an externalprogramming unit, according to the invention;

FIG. 6 is a schematic block diagram of one embodiment of a database,according to the invention;

FIG. 7 is a flowchart of one embodiment of a method for adjustingstimulation parameters, according to the invention;

FIG. 8 is a flowchart of one embodiment of a method for testing a rangeof stimulation parameters, according to the invention;

FIG. 9 is a flowchart of one embodiment of a method for requestingpatient authorization for using patient data, according to theinvention;

FIG. 10 is a flowchart of another embodiment of a method for obtainingstimulation recommendations, according to the invention;

FIG. 11 is a schematic side view of one embodiment of a lead and controlmodule, according to the invention;

FIG. 12 is a schematic side view of another embodiment of a lead andcontrol module, according to the invention;

FIG. 13A is a schematic side view of one embodiment of an implantablecontrol module configured and arranged to electrically couple to anelongated device, according to the invention; and

FIG. 13B is a schematic side view of one embodiment of a lead extensionconfigured and arranged to electrically couple an elongated device to animplantable control module, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the area of implantable electricalstimulation systems and methods of making and using the systems. Thepresent invention is also directed to implantable electrical stimulationsystems include devices or methods for providing feedback regardingelectrical stimulation, as well as methods of making and using theelectrical stimulation systems.

Suitable implantable electrical stimulation systems include, but are notlimited to, a least one lead with one or more electrodes disposed alonga distal end of the lead and one or more terminals disposed along theone or more proximal ends of the lead. Leads include, for example,percutaneous leads, paddle leads, and cuff leads. Examples of electricalstimulation systems with leads are found in, for example, U.S. Pat. Nos.6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,949,395;7,244,150; 7,672,734; 7,761,165; 7,974,706; 8,175,710; 8,224,450; and8,364,278; and U.S. Patent Application Publication No. 2007/0150036, allof which are incorporated by reference in their entireties.

An electrical stimulation system can include a local or non-localnetwork of devices that can be used in a session to program, visualizeor interact during a medical office procedure, such as a session toprogram a neurostimulator. In at least some embodiments, the systemallows a patient to provide feedback on the effects of the therapy whilethe clinician or programmer adjusts the parameters of the medicaldevice.

For example, the clinician or programmer uses an external programmingunit that communicates (directly or through a secondary device) with animplantable control module that delivers therapy or stimuli to apatient. The clinician or programmer perceives or receives from thepatient feedback regarding the clinical effects of the stimuli. Thefeedback can then be recorded into the external programming unit orother components of the system (locally or remotely). This feedback isutilized to define a clinical effects map that correlates therapydelivered with the clinical effects experienced. Alternatively oradditionally, both the programmer and the patient may input the clinicaleffects into the system. The patient may provide feedback to theprogramming unit via a patient interface unit. Patient feedback may alsobe recorded as bio-signals from the patient (EEG, EMG, CMAP, ECG, skinresistance, muscle tone, movement, vibration, rigidity, temperature,breathing, oxygen levels, chemical concentrations, skin resistance,gait, skin tone, force, pressure, and the like.)

FIG. 1 illustrates schematically one embodiment of an electricalstimulation system 100 that includes an implantable control module(e.g., an implantable electrical stimulator or implantable pulsegenerator) 102, one or more leads 108 with electrodes, one or moreexternal programming units 106, and a patient interface unit 105.Alternatively, the implantable control module 102 can be part of amicrostimulator with the electrodes disposed on the housing of themicrostimulator. The microstimulator may not include a lead or, in otherembodiments, a lead may extend from the microstimulator. It will beunderstood that the electrical stimulation system can include more,fewer, or different components and can have a variety of differentconfigurations including those configurations disclosed in thereferences cited herein. For example, although FIG. 1 illustrates oneexternal programming units 106, one control module 102, and one patientinterface unit 105, it will be understood that the system can includemore than one external programming unit, more than one control module,and more than one patient interface unit.

The lead 108 is coupled, or coupleable, to the implantable controlmodule 102. The implantable control module 102 includes a processor 110,an antenna 112 (or other communications arrangement), a power source114, and a memory 116, as illustrated in FIG. 1.

FIG. 2 illustrates another embodiment that includes a database 104 withcommunicates with the external programming unit 106 and optional patientinterface unit 105. FIG. 3A illustrates another embodiment in which theexternal programming unit 106 and optional patient interface unit 105communicate through the Internet, a cloud, or a local or wide areanetwork 107 (including wireless local or wide area networks) or anycombination thereof, or any other suitable intermediary or combinationof intermediaries, to the database 104.

One example of a patient interface unit 105 is illustrated in FIG. 4 andincludes a processor 150, a memory 152, a communications arrangement 154(such as an antenna or any other suitable communications device such asthose described below), and an optional user interface 156. Suitabledevices for use as a patient interface unit can include, but are notlimited to, a computer, a tablet, a mobile telephone, a personal deskassistant, a dedicated device for external programming, remote control,or the like. In at least some embodiments, the patient interface unit105 can also be an external programming unit.

One example of an external programming unit 106 is illustrated in FIG. 5and includes a processor 160, a memory 162, a communications arrangement164 (such as an antenna or any other suitable communications device suchas those described below), and a user interface 166. Suitable devicesfor use as an external programming unit can include, but are not limitedto, a computer, a tablet, a mobile telephone, a personal desk assistant,a dedicated device for external programming, remote control, or thelike. It will be understood that the external programming unit 106 andpatient interface unit 105 can include a power supply or receive powerfrom an external source or any combination thereof. In at least someembodiments, the external programming unit 106 may also be a patientinterface unit.

One example of a database 104 is illustrated in FIG. 4 and includes aprocessor 140, a memory 142, a communications arrangement 144 (such asan antenna or any other suitable communications device such as thosedescribed below), and an optional user interface 146. Suitable devicesfor use as a remote data storage unit can include, but are not limitedto, a computer, a tablet, a server or server farm, a dedicated devicefor data storage, a hard drive, cloud storage arrangement, or the like.It will be understood that the external programming unit 106 and remotedata storage unit 104 can include a power supply or receive power froman external source or any combination thereof. In some embodiments, thedatabase 104 can also act as a remote storage unit for storage andretrieval of stimulation parameters and other stimulation data. Examplesof remote storage units and their use and operation in electricalstimulation systems can be found in U.S. Provisional Patent ApplicationSer. No. 62/028,688, incorporated herein by reference in its entirety.

Methods of communication between devices or components of a system caninclude wired or wireless (e.g., RF, optical, infrared, near fieldcommunication (NFC), Bluetooth™, or the like) communications methods orany combination thereof. By way of further example, communicationmethods can be performed using any type of communication media or anycombination of communication media including, but not limited to, wiredmedia such as twisted pair, coaxial cable, fiber optics, wave guides,and other wired media and wireless media such as acoustic, RF, optical,infrared, NFC, Bluetooth™ and other wireless media. These communicationmedia can be used for communications units 144, 154, 164 or as antenna112 or as an alternative or supplement to antenna 112.

Turning to the control module 102, some of the components (for example,a power source 114, an antenna 112, and a processor 110) of theelectrical stimulation system can be positioned on one or more circuitboards or similar carriers within a sealed housing of the control module(implantable pulse generator,) if desired. Any power source 114 can beused including, for example, a battery such as a primary battery or arechargeable battery. Examples of other power sources include supercapacitors, nuclear or atomic batteries, mechanical resonators, infraredcollectors, thermally-powered energy sources, flexural powered energysources, bioenergy power sources, fuel cells, bioelectric cells, osmoticpressure pumps, and the like including the power sources described inU.S. Pat. No. 7,437,193, incorporated herein by reference in itsentirety.

As another alternative, power can be supplied by an external powersource through inductive coupling via the antenna 112 or a secondaryantenna. The external power source can be in a device that is mounted onthe skin of the user or in a unit that is provided near the user on apermanent or periodic basis.

If the power source 114 is a rechargeable battery, the battery may berecharged using the antenna 112, if desired. Power can be provided tothe battery for recharging by inductively coupling the battery throughthe antenna to a recharging unit external to the user.

A stimulation signal, such as electrical current in the form ofelectrical pulses, is emitted by the electrodes of the lead 108 (or amicrostimulator) to stimulate neurons, nerve fibers, muscle fibers, orother body tissues near the electrical stimulation system. Examples ofleads are described in more detail below. The processor 110 is generallyincluded to control the timing and electrical characteristics of theelectrical stimulation system. For example, the processor 110 can, ifdesired, control one or more of the timing, frequency, strength,duration, and waveform of the pulses. In addition, the processor 110 canselect which electrodes can be used to provide stimulation, if desired.In some embodiments, the processor 110 selects which electrode(s) arecathodes and which electrode(s) are anodes. In some embodiments, theprocessor 110 is used to identify which electrodes provide the mostuseful stimulation of the desired tissue.

With respect to the control module 102, patient interface unit 105,external programming unit 106, and database unit 104, any suitableprocessor 110, 140, 150, 160 can be used in these devices. For thecontrol module 102, the processor 110 is capable of receiving andinterpreting instructions from an external programming unit 106 that,for example, allows modification of pulse characteristics. In theillustrated embodiment, the processor 110 is coupled to the antenna 112.This allows the processor 110 to receive instructions from the externalprogramming unit 106 to, for example, direct the pulse characteristicsand the selection of electrodes, if desired. The antenna 112, or anyother antenna described herein, can have any suitable configurationincluding, but not limited to, a coil, looped, or looplessconfiguration, or the like.

In one embodiment, the antenna 112 is capable of receiving signals(e.g., RF signals) from the external programming unit 106. The externalprogramming unit 106 can be a home station or unit at a clinician'soffice or any other suitable device. In some embodiments, the externalprogramming unit 106 can be a device that is worn on the skin of theuser or can be carried by the user and can have a form similar to apager, cellular phone, or remote control, if desired. The externalprogramming unit 106 can be any unit that can provide information to thecontrol module 102. One example of a suitable external programming unit106 is a computer operated by the user or clinician to send signals tothe control module 102. Another example is a mobile device or anapplication on a mobile device that can send signals to the controlmodule 102

The signals sent to the processor 110 via the antenna 112 can be used tomodify or otherwise direct the operation of the electrical stimulationsystem. For example, the signals may be used to modify the pulses of theelectrical stimulation system such as modifying one or more of pulseduration, pulse frequency, pulse waveform, and pulse strength. Thesignals may also direct the control module 102 to cease operation, tostart operation, to start charging the battery, or to stop charging thebattery.

Optionally, the control module 102 may include a transmitter (not shown)coupled to the processor 110 and the antenna 112 for transmittingsignals back to the external programming unit 106 or another unitcapable of receiving the signals. For example, the control module 102may transmit signals indicating whether the control module 102 isoperating properly or not or indicating when the battery needs to becharged or the level of charge remaining in the battery. The processor110 may also be capable of transmitting information about the pulsecharacteristics so that a user or clinician can determine or verify thecharacteristics.

Any suitable memory 116, 142, 152, 162 can be used for the respectivecomponents of the system 100. The memory 116, 142, 152, 162 illustratesa type of computer-readable media, namely computer-readable storagemedia. Computer-readable storage media may include, but is not limitedto, nonvolatile, removable, and non-removable media implemented in anymethod or technology for storage of information, such as computerreadable instructions, data structures, program modules, or other data.Examples of computer-readable storage media include RAM, ROM, EEPROM,flash memory, or other memory technology, CD-ROM, digital versatiledisks (“DVD”) or other optical storage, magnetic cassettes, magnetictape, magnetic disk storage or other magnetic storage devices, or anyother medium which can be used to store the desired information andwhich can be accessed by a computing device.

Communication methods provide another type of computer readable media;namely communication media. Communication media typically embodiescomputer-readable instructions, data structures, program modules, orother data in a modulated data signal such as a carrier wave, datasignal, or other transport mechanism and include any informationdelivery media. The terms “modulated data signal,” and “carrier-wavesignal” includes a signal that has one or more of its characteristicsset or changed in such a manner as to encode information, instructions,data, and the like, in the signal. By way of example, communicationmedia includes wired media such as twisted pair, coaxial cable, fiberoptics, wave guides, and other wired media and wireless media such asacoustic, RF, infrared, and other wireless media.

The user interfaces 156, 166 of the external programming unit 106 andpatient interface unit 105 and optional user interface 146 of thedatabase 104 can be, for example, a keyboard, mouse, touch screen, trackball, joystick, voice recognition system, or any combination thereof,and the like. Alternatively or additionally, the user interfaces 156,166 of the external programming unit 106 and of the patient interfaceunit 105 can include one or more microphones, sensors, cameras, or thelike to obtain patient feedback. For example, the patient may providefeedback verbally (e.g. voice command recognition, voice recordings) orvisually (e.g. video of patient, non-touch gesture recognition, or thelike). In at least some embodiments, at least a portion (or even all of)the patient feedback may be recorded as bio-signals from the patient(EEG, EMG, CMAP, ECG, skin resistance, muscle tone, movement, vibration,rigidity, temperature, breathing, oxygen levels, chemicalconcentrations, skin resistance, gait, skin tone, force, pressure, orthe like.) In at least some embodiments, such as those illustrated inFIGS. 2 and 3 without the optional patient interface unit, patientfeedback can be provided by the clinician or other user through theexternal programming unit 106.

In at least some embodiments, the patient interface unit 105 may alsohave controls to adjust parameters of the stimulation, which areoptionally limited to an acceptable range by the clinician (using thepatient interface unit or external programming unit) or by defaultsettings of the electrical stimulation system or control module or anyother suitable mechanism. Such parameters can include, for example, oneor more of stimulation amplitude range, stimulation frequency range,stimulation pulse width, stimulation duration, interval between deliveryof stimulation, electrode combinations, selection of anode(s) andcathode(s), or the like or any combination thereof.

In at least some embodiments, as the person delivering therapy adjustsstimulation parameters using the external programming unit 106, thepatient can then use the patient interface unit 105 to identify theeffects of the stimulation parameters. For example, the patient canindicate in which areas of the body there is perception of stimulation(e.g. paresthesia) or indicate a pain level or indicate a score forsatisfaction with treatment, or any combination thereof. In at leastsome embodiments, the patient interface unit 105 may also allow thepatient to input areas where the patient needs or desires morestimulation and areas where the patient needs or desires lessstimulation (for example, areas with side effects). This information canbe provided to the external programming unit 106 for the programmer toadjust stimulation parameters.

In at least some embodiments, the system utilizes a figure of merit ofthe adequacy, or a rating, of the stimulation provided. The figure ofmerit can be based on, for example, one or more of the following:therapeutic effect, patient satisfaction, level or presence of sideeffects, patient dissatisfaction, or the like or any combinationthereof. The figure of merit can be, for example, a numerical value, analphanumerical rating, a descriptive rating, or any other suitablerating mechanism or any combination thereof. The figure of merit may beprovided by the clinician, the patient, or both and can be input throughthe external programming unit 106, patient interface unit 105, or otherdevice or any combination of these or other devices. In at least someembodiments, the figure of merit can be used to enhance, adjust, orguide stimulation delivery.

The figure of merit may be determined from multiple ratings provided bythe clinician, the patient, or both. In at least some embodiments, thedetermination of a figure of merit may employ different weights todifferent parameters in the calculation. For example, the determinationmay add more value to certain preferred clinical outcomes, may add morenegative value to particular side effects, may add less negative valueto power consumption, or the like. The weights and parameters enteringthe figure of merit may be defined by the users of the system (e.g.patient, clinician, programmer, or any combination thereof) or may bepre-set by the system. The system may allow different users to definedifferent figures of merit that can be optionally shared via the system.

FIG. 7 is a flowchart of one embodiment of a method of adjustingstimulation parameters. In step 702, patient feedback is requested. Therequest can be made on the external programming unit, patient interfaceunit, or using any other suitable device or method, or any combinationthereof. In step 704, the patient feedback is obtained. The patient mayprovide the feedback directly to the system through, for example, thepatient interface unit or may provide the feedback to the clinician whoinputs the feedback through, for example, the external programming unit.In step 706, the system analyzes the feedback and providesrecommendations for adjusting the stimulation parameters based on thepatient feedback. In some embodiments, the analysis, or portions of theanalysis, may be performed by the external programming unit or anotherlocal device. In some embodiments, the analysis, or portions of theanalysis, can be performed using a remote device.

In at least some embodiments, the system may allow creation of differenttherapeutic options based, for example, on different figures of merit orsituations for the patient. Each therapeutic option may have one or moredifferent stimulation parameters from other therapeutic options. Forexample, the system may provide or allow different stimulation programsfor one or more of the following conditions or situations: sleep,walking, condition exacerbation, acute episodes, preventative therapies,activity based, and the like. In at least some embodiments, the patientuser interface 105 or the external programming unit 106 may be designedto create multiple areas of stimulation and multiple programs to targetdifferent areas.

In at least some embodiments, the stimulation controls of the externalprogramming unit 106 or, optionally, the patient interface unit 105 maybe designed to allow changing the shape of the stimulation area, size ofthe stimulation area, strength of the stimulation, perception pattern(for example, type of sensation or no sensation) of the stimulation, orthe like, or any combination thereof. In at least some embodiments, theexternal programming unit 106 or, optionally, the patient interface unit105 may allow a user to move the stimulation to different anatomicalareas (for example, using directional controls, such as arrows, or ajoystick or mouse or other mechanism) or by marking areas in a maprepresenting the body. In at least some embodiments, the externalprogramming unit 106 or, optionally, the patient interface unit 105 mayallow a use to increment or decrement stimulation in certain areas ofthe body or to add or remove stimulation from certain areas of the body.In at least some embodiments, the external programming unit 106 or,optionally, the patient interface unit 105 may allow a user (forexample, a clinician or a patient) to increase or decrease the intensityof stimulation in areas of the body. In at least some embodiments, theseareas can be mapped by the patient using the patient interface unit 105.

In at least some embodiments, a human figure, or parts of human anatomy,can be depicted in 2-dimensional and/or 3-dimensional representations onthe patient user interface unit 105 or the external programming unit 106to allow the user (for example, a patient or a clinician) to input areasof the body that, for example, experience stimulation-induced effects(for example, where stimulation is perceived or where stimulation isevidenced), experience pain, are desired stimulation areas, are areaswhere stimulation is not desired, are areas where side effects occur, orthe like or any combination thereof. In at least some embodiments, theareas of the body can be marked based on level of intensity ofstimulation, pain, or side effects or any other suitable parameter. Inat least some embodiments, the user can indicate different levels ofintensity, for example, areas of intense pain or mild pain, or areas ofintense stimulation or mild stimulation). It will be recognized thatmore than two different levels of intensity can be represented. Inaddition, in at least some embodiments, aspects of the reported pain,stimulation, or side effects (or any combination thereof) may berecorded in addition to the intensities of said effects. For example,pain quality (for example, tingling, burning, stabbing, shooting,throbbing, or the like), stimulation quality (for example, tingling,buzzing, hot, cold, cool, warm, or the like), other characteristics (forexample, worst pain, overall pain, pain that is ‘superficial’ or ‘deep’,stimulation effects which are ‘superficial’ or ‘deep’, or the like), orany combination thereof can be recorded.

FIG. 8 is a flowchart of one embodiment of a method of testing a rangeof stimulation parameters. In step 802, the patient is stimulated over arange of stimulation parameters. In some embodiments, only a singlestimulation parameter (for example, stimulation amplitude, stimulationduration, selection of electrodes) is varied over a range. In otherembodiments, more than one stimulation parameter is varied. In step 804,the patient feedback is obtained. The patient may provide the feedbackdirectly to the system through, for example, the patient interface unitor may provide the feedback to the clinician who inputs the feedbackthrough, for example, the external programming unit. In step 806, thesystem analyzes the feedback and presents the clinical effects (forexample, patient feedback, stimulation efficacy, presence of sideeffects, strength of side effects, or any combination thereof) for therange of stimulation parameters. In some embodiments, the system mayalso provide recommendations for the stimulation parameters based on thepatient feedback. In some embodiments, the analysis, or portions of theanalysis, may be performed by the external programming unit or anotherlocal device. In some embodiments, the analysis, or portions of theanalysis, can be performed using a remote device.

In at least some embodiments, the system stores the differenttherapeutic options, clinical effects map, figures of merit of theparticular patient in one or more of the control module 102, theexternal programming unit 106, patient user interface 105, or remotedatabase 104. In at least some embodiments, the clinical effectsobserved by the clinician or reported by the patient are stored inrelation to the particular set of parameters associated therewith. Theparameters of the stimulation can include the stimulation parameters atthe time of feedback or may also include historical information, such asthe parameters used for stimulation delivered over a period of time.

In at least some embodiments, the external programming unit 106, controlmodule 102, or patient interface unit 105 (or any combination thereof)may be configured to adjust the stimulation parameters in a selectedpattern either automatically or semi-automatically (with some usercontrol over selection of which parameters to test or sets of initialparameters) to create a map of clinical effects over a related set ofstimulation conditions. For example, an algorithm may guide several setsof parameters and stimulation combinations in a given order and recordclinical effects as the different parameter sets are exercised. Asanother example, an algorithm can adjust one or more of amplitude,frequency, duration, electrode selection, or the like or any combinationthereof to obtain a map of clinical effects for varied stimulationparameters. In at least some embodiments, the patient, user, or systemcan provide information, ratings, or figures of merit for the differentsets of stimulation parameters.

The system can also incorporate demographics (for example, age, gender,ethnicity, height, weight, or the like) and disease-specific details(for example, pain etiology(ies), number of prior back surgeries,relevant diagnoses, imaging findings, or the like) in the informationprovided to the external programming unit 106, control module 102, orpatient interface unit 105 (or any combination thereof).

In at least some embodiments, the system may also be capable ofreceiving medical imaging information (for example, photographs, video,MRI images, CT scans, ultrasound images, anatomical atlases, or thelike) and device information. The system may be configured to allow auser to upload MRI scans, CT scans, ultrasound images, or othervisualization information of the anatomical targets for stimulation. Inat least some embodiments, the system or a user may also correlate thisvisualization information to the position of the lead and electricalcontacts to aid in the recommendation of stimulation targets andelectrode combinations.

In at least some embodiments, information obtained from a programming orpatient interactive session can be recorded and stored on one or more ofthe control module 102, the external programming unit 106, patient userinterface 105, or remote database 104. This information may be used toprovide additional statistical data to correlate stimulation parameters,targets of stimulation, anatomical placements, lead configurations,diagnostics, symptoms, patient characteristics, or the like. Thisinformation may also be used to inform a statistical-based algorithmthat aggregates the information and calculates potential or recommendlead or electrode configurations for the patient. Such configurations,the underlying information, or portions of the information may be madeavailable to other programmers, clinicians, or patients.

In at least some embodiments, the system may use information (forexample, stimulation parameters, patient or clinician feedback, figuresof merit, ratings, or the like) inputted to one or more of the controlmodule 102, the external programming unit 106, patient user interface105, or remote database 104 to calculate derived metrics that can beused by the programmer to assess programming effectiveness. Examplesinclude stimulation effectiveness, pain/paresthesia concordance, worstpain/paresthesia concordance, quantification of the degree to which thepain that has ‘neuropathic’ descriptors assigned to it by the patient iscovered with stimulation, quantification of the degree to which painthat has ‘nociceptive’ or ‘pain’ descriptors assigned to it by thepatient is covered with stimulation, side effect correlation toparameters or location, or the like.

In at least some embodiments, the system can use the patient- orclinician-provided feedback to automatically adjust stimulationparameters. For example, if the patient or clinician marks an area astoo intense the system may automatically reduce the stimulationamplitude in that area (by changing electrode combinations or electricalparameters of the electrodes), or it could recommend a next settings ofparameters which the user can accept or migrate to. In at least someembodiments, the system can determine or present a “target volume ofactivation” and the user may adjust stimulation parameters to overlapthe target.

In at least some embodiments, the system contains information regardingtargets based on historical and statistical data within a single patientor across many patients. For example, a depiction of a human andselection of areas of pain can produce a pain map that can be utilizedto input areas of pain (or other symptoms) by the patient or clinicianor both. In at least some embodiments, the system can use this pain mapto provide recommended target volumes of activation (where electriccurrent should be delivered) or recommended initial stimulationparameters or recommended stimulation parameter ranges for testing. Thisinformation can be used to plan for the surgical procedure to implantthe control module and lead(s) and programming of the control module.

In at least some embodiments, the feedback provided or perceived fromthe patient or clinician is mapped in the patient interface unit 105,external programming unit 106, or database 104 or any combinationthereof and can be available to be used by the system to providefeedback to the user to aid in the stimulation adjustment. In at leastsome embodiments, the system may use the information to provide arecommended next step for adjustment of stimulation parameters or otheradjustment to therapeutic treatment. In at least some embodiments, thesystem may use the information and aggregate it with information fromthe same or other patients to create a statistical estimation ofclinical effects in relation to stimulation parameters, usercharacteristics, or any combination thereof.

In at least some embodiments, the system transmits data collected fromthe patient (for example, clinical effects, patient or clinicianfeedback, stimulation parameters, or any combination thereof) to betransmitted to the database 104. The information in the database 104 maybe used for aggregation and recommendation of stimulation adjustments ata different clinical session or may be provided to the patient orclinician to download into his/her devices (e.g., control module 102,the external programming unit 106, patient user interface 105, personaldevices or database, or the like or any combination thereof).

For data aggregation, the user (for example, clinician, patient, orother user) may choose to aggregate a group of data (for example, datafrom a particular patient set to a given medical center or centers) ormay choose to aggregate data from a larger group of patients. Dataaggregation can be executed from a local system (relative to theclinician, patient, site of surgery, or the like) or may be doneremotely (e.g. remote database and cloud computing).

In at least some embodiments, the system has a feature for the patientto authorize the information to be used in the aggregation of data orexported for further analysis. For example, the patient may produce anelectronic signature, paper signature that is recorded, video or audioauthorizing the aggregation, or the like. If the patient authorizes dataaggregation, the patient's data can be used for analysis by the systemto inform programming or stimulation delivery to other patients or toanalyze further. If the patient does not authorize the information to beused, the system will exclude the patient's data from the aggregation ofdata from other patients. In at least some embodiments, the systemexcludes patient identification data for aggregation, export oranalysis.

FIG. 9 is a flowchart of one embodiment of a method of obtaining patientauthorization. In step 902, the system requests patient authorization.The request can be made through the clinician, through the externalprogramming unit, or the patient interface unit or any other suitablemechanism. In step 904, the patient authorization is obtained. In atleast some embodiments, that authorization is in the form of anelectronic signature, paper signature that is recorded, video or audioauthorizing the aggregation, or the like. In step 906, the patientauthorization and authorized patient data is submitted to the database.This submission of authorization and data may be performedsimultaneously or performed at different times. If the data has beenpreviously submitted to the database, the patient's authorization may beused to allow the previously submitted data to be aggregated with otherdata.

In at least some embodiments, the system may also allow experiencedprogrammers of the stimulation system to propose stimulation parameteror lead configurations which can be downloaded by other users of thesystem.

In at least some embodiments, multiple external programming units 106,patient interface units 105, or any combination thereof can be connectedeither locally or remotely into a network (local or wide area orvirtual) allowing multiple programmers or users at the same time. In atleast some embodiments, when multiple programmers are using a system,the system can be configured to allow several programmers to work at thesame time or at different times. In at least some embodiments, thesystem can also be configured to allow different priorities betweenusers. In at least some embodiments, the system can also be configuredto allow particular functions to take precedence regardless of who isthe user (for example, an emergency stimulation shut down command).

In at least some embodiments, the aggregation of data can include thecreation of target stimulation maps for particular pain conditions. Thesystem can aggregate effective stimulation parameters for many patientswho experience pain due to different conditions and different locationsin the body. The system (automatically, semi-automatically, or withclinician input) can evaluate, based on figures of merit or otherfeedback or data from each of the patients, and provide a statisticaltarget area to stimulate in the spinal cord of a patient to ensuremaximum likelihood of success, based on the figure of merit. In at leastsome embodiments, a clinician can then input the pain condition of thepatient and read from the target stimulation map the recommendedstimulation locations or parameters or both and a statisticaldistribution of results. In at least some embodiments, the system canprovide a visual anatomical representation of the target area (forexample, as a single point, a surface, an anatomical structure, or avolume). The target of activation may also be determined via functionaloutcomes of stimulation (e.g. one vertebral space above area where toeflexion occurs during stimulation). In at least some embodiments, thisinformation can be used to plan the placement of the electrodes. In atleast some embodiments, once the electrodes are in place, the locationof the electrodes relative to the spinal cord can be input to thesystem. In at least some embodiments, the system can then recommend oneor more sets of stimulation parameters or parameter ranges to placestimulation in the target area.

In at least some embodiments, the target area may be represented in thesystem and a volume of activation based on current stimulationparameters to visually indicate the amount of overlap (and non-overlap)of target volume and volume of activation. In at least some embodiments,the system may provide surface or volumetric measures of overlap andnon-overlap. The user can use the stimulation controls to placestimulation in the target or as close as adequate. This is particularlyuseful for indications in which patients may not feel the stimulation orin which the effects of stimulation take too long to be measured duringa programming session. In at least some embodiments, the user can alsouse patient feedback to set the target of stimulation.

FIG. 10 is a flowchart of one embodiment of a method of obtainingrecommendations for stimulation sites, parameters, or any combinationtherefrom from the system. In step 1002, the pain condition is inputinto the system using, for example, the external programming unit, thepatient interface unit, or any other input device. The pain conditioncan be expressed in any suitable manner that is accepted by the system,such as, for example, descriptive text, selection from a list of painsites or symptoms or other indicators, identification of pain regions onan anatomical representation, or any other suitable method of indicatingthe source, symptom, or site of the pain. In step 1004, the systemcorrelates the information provided on the pain condition with theaggregated data. Such correlation may be made with the data directly orwith a previously prepared correlation construct, such as a targetstimulation map, pain map, pain concordance, or the like, produced usingthe aggregated data. In step 1006, recommendations for stimulation areprovided by the system to the clinician, patient, or other user. Theserecommendations can include one or more of the following: stimulationsite, initial stimulation parameters, stimulation parameter ranges, orany combination thereof.

It will be understood that the system can include one or more of themethods described hereinabove with respect to FIGS. 7-10 in anycombination. The methods, systems, and units described herein may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein. Accordingly, the methods, systems,and units described herein may take the form of an entirely hardwareembodiment, an entirely software embodiment or an embodiment combiningsoftware and hardware aspects. The methods described herein can beperformed using any type of processor or any combination of processorswhere each processor performs at least part of the process.

It will be understood that each block of the flowchart illustrations,and combinations of blocks in the flowchart illustrations and methodsdisclosed herein, can be implemented by computer program instructions.These program instructions may be provided to a processor to produce amachine, such that the instructions, which execute on the processor,create means for implementing the actions specified in the flowchartblock or blocks or described for the control modules, externalprogramming units, remote data storage units, systems and methodsdisclosed herein. The computer program instructions may be executed by aprocessor to cause a series of operational steps to be performed by theprocessor to produce a computer implemented process. The computerprogram instructions may also cause at least some of the operationalsteps to be performed in parallel. Moreover, some of the steps may alsobe performed across more than one processor, such as might arise in amulti-processor computer system. In addition, one or more processes mayalso be performed concurrently with other processes, or even in adifferent sequence than illustrated without departing from the scope orspirit of the invention.

The computer program instructions can be stored on any suitablecomputer-readable medium including, but not limited to, RAM, ROM,EEPROM, flash memory or other memory technology, CD-ROM, digitalversatile disks (“DVD”) or other optical storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium which can be used to store the desired informationand which can be accessed by a computing device.

As indicated above, information from multiple patients can be aggregatedin a database 104 and used to provide recommendations for stimulationprograms, stimulation parameters, or stimulation adjustments that can beprovided to one or more devices, such as, for example, a control module102, an external programming unit 106, a patient user interface 105,personal devices or another database, or the like or any combinationthereof. FIG. 3B illustrates an arrangement with multiple externalprogramming units 106 a, 106 b, 106 c and multiple patient userinterfaces 105 a, 105 b, 105 c that can access a database 104 throughthe Internet, a cloud, or a local or wide area network 107, or anycombination thereof. In at least some embodiments, the database 104 canbe a repository or store for obtaining stimulation programs, stimulationparameters, stimulation adjustments, therapy recommendation or guidance,lead placement information, or other information for use in providingtherapy to a patient. In some embodiments, the database 104 can be avirtual therapy store or part of such a store or accessible by, orthrough, such a store.

The database 104 can include information such as, for example,stimulation settings, stimulation logs, program usage, implant or leadlocations, and other information obtained from the control module 102,external programming unit 106, patient user interface 105, or any othersuitable device. The database 104 may be directed to a specific type ofstimulation therapy, such as, for example, deep brain stimulation orspinal cord stimulation or peripheral nerve stimulation, or may bedirected to multiple, or all, types of stimulation therapy. The database104 may also include information from other sources including, but notlimited to, patient questionnaires; scores given by clinicians orpatients for particular stimulation parameters, locations, or devices(the scores are optionally based on established scales); or any othersuitable information. The database 104 may also include informationgathered from internal or external sensors, such as those described inU.S. patent application Ser. No. 14/876,708 and U.S. patent applicationSer. No. ______, entitled “Systems, Devices, and Methods for ElectricalStimulation Using Sensors to Adjust Stimulation Parameters,” filed oneven date herewith (Attorney Docket No. BSNC-1-375.2), both of which areincorporated by reference in their entireties.

In at least some embodiments, machine learning or other algorithms maybe used to analyze the data on the database 104 to identify correlationsbetween treatment efficacy and one or more stimulation variablesincluding, but not limited to, one or more of lead or electrodeplacement; stimulation parameters (e.g., electrode selection,stimulation amplitude, stimulation duration, pulse frequency, pulseduration, or the like); disease or disorder or condition being treated;patient demographics (e.g., age, ethnicity, gender, activity level,weight, or the like); physical activity; or the like or any combinationthereof. In at least some embodiments, these algorithms can generate newstimulation programs or sets of stimulation parameters or improveexisting stimulation programs or sets of stimulation parameters. In atleast some embodiments, the results of these algorithms may be tailoredto a particular group of patients; one or more specific patientcharacteristics; one or more specific diseases or disorders orconditions; one or more specific symptoms; a lead or electrodeplacement; one or more specific devices or leads; one or more types ofstimulation; or the like or any combination thereof.

In at least some embodiments, the database 104 may include previouslyuploaded stimulation programs or sets of stimulation parameters;internally or externally generated stimulation programs or sets ofstimulation parameters (generated using, for example, machine learningor other algorithms); improved stimulation programs or sets ofstimulation parameters; or the like or any combination thereof. In atleast some embodiments, these stimulation programs or sets ofstimulation parameters (or other information in the database 104) may bedownloaded by a patient, clinician, or other person onto a controlmodule 102, external programming unit 106, patient user interface 105,or any other suitable device. In at least some embodiments, downloadingof some or all of the information may be limited to specific users(e.g., clinicians or paying subscribers).

In at least some embodiments, the database 104 may be part of an onlinevirtual store (or accessed or accessible via an online virtual store) tooffer patients or clinicians the stimulation programs or sets ofstimulation parameters or other information for download. In at leastsome embodiments, the online virtual store may be similar in style orpresentation to current online application stores such as iTunes™ orGoogle Play™ stores. In at least some embodiments, the database or storemay group the stimulation programs or sets of stimulation parameters incategories based on, for example, disease or disorder or condition; typeof stimulation (e.g., deep brain, spinal cord, peripheral nerve);symptom(s); area of symptom manifestation (for example, area of pain);lead or electrode placement; type of lead or device; physical activitytype; or any other suitable category. In at least some embodiments, thestore or database may allow patients, clinicians, or others to provideratings for the stimulation programs or sets of stimulation parameters.In at least some embodiments, the store or database may allow patients,clinicians, or others to provide reviews or recommendations for thestimulation programs or sets of stimulation parameters. The database orstore may restrict which individuals can provide reviews (e.g.,clinicians or paying subscribers). In at least some embodiments, thestore or database may allow patients, clinicians, or others to uploadtheir own stimulation programs or sets of stimulation parameters withcomments from the uploader. In at least some embodiments, the store ordatabase may provide a social platform for patients, clinicians, orothers, or any combination thereof to discuss the stimulation programsor sets of stimulation parameters or provide comments, suggestions,advice, or other information regarding the stimulation programs or setsof stimulation programs or how to modify the programs or parameters.

In at least some embodiments, the database store can be personalized andprovide patient specific therapy recommendations. These recommendationscan be made by the clinician, representative of a manufacturer ordistributor of devices, or based of the patient history and analysis onneuromodulation data stored on the database or devices. In at least someembodiments, the database or store can also provide features withfiltering capabilities (for example, highest or most rated programs aspecific disease or disorder or condition, programs linked to aparticular lead placement, alternative programs with lower energysettings, and the like) and general search functions. In at least someembodiments, the database or store can also provide a “one click” optionfor a patient, clinician, or other person to download any selectedprogram to a control module 102, external programming unit 106, patientuser interface 105, or any other suitable device. In some embodiments, acontrol module 102 or other device may include clinician-selected safetylimits to limit downloaded stimulation programs or sets of stimulationparameters. In at least some embodiments, the database or store canprovide free or paid options for trying new stimulation programs or setsof stimulation parameters.

In at least some embodiments, a patient can perform self-programmingusing a patient user interface 105. With each patientsteering/navigation, the system connects to the database 104 to runalgorithm and return the program parameters. In at least someembodiments, device updates or new algorithms can be deployed to thedatabase 104 and all connected devices (e.g., control modules 102,external programming units 106, patient user interfaces 105, or othersuitable devices) can download (either automatically or manually) theupdates or algorithms.

FIG. 11 illustrates one embodiment of a control module 402 and lead 403.The lead 403 includes a paddle body 444 and one or more lead bodies 446.In FIG. 11, the lead 403 is shown having two lead bodies 446. It will beunderstood that the lead 403 can include any suitable number of leadbodies including, for example, one, two, three, four, five, six, seven,eight or more lead bodies 446. An array of electrodes 433, such aselectrode 434, is disposed on the paddle body 444, and one or moreterminals (e.g., 560 in FIGS. 13A and 13B) are disposed along each ofthe one or more lead bodies 446. In at least some embodiments, the leadhas more electrodes than terminals.

FIG. 12 illustrates schematically another embodiment in which the lead403 is a percutaneous lead. In FIG. 12, the electrodes 434 are showndisposed along the one or more lead bodies 446. In at least someembodiments, the lead 403 is isodiametric along a longitudinal length ofthe lead body 446.

The lead 403 can be coupled to the implantable control module 402 in anysuitable manner. In FIG. 11, the lead 403 is shown coupling directly tothe implantable control module 402. In at least some other embodiments,the lead 403 couples to the implantable control module 402 via one ormore intermediate devices (500 in FIGS. 13A and 13B). For example, in atleast some embodiments one or more lead extensions 524 (see e.g., FIG.13B) can be disposed between the lead 403 and the implantable controlmodule 402 to extend the distance between the lead 403 and theimplantable control module 402. Other intermediate devices may be usedin addition to, or in lieu of, one or more lead extensions including,for example, a splitter, an adaptor, or the like or combinationsthereof. It will be understood that, in the case where the electricalstimulation system includes multiple elongated devices disposed betweenthe lead 403 and the implantable control module 402, the intermediatedevices may be configured into any suitable arrangement.

In FIG. 12, the electrical stimulation system 400 is shown having asplitter 457 configured and arranged for facilitating coupling of thelead 403 to the implantable control module 402. The splitter 457includes a splitter connector 458 configured to couple to a proximal endof the lead 403, and one or more splitter tails 459 a and 459 bconfigured and arranged to couple to the implantable control module 402(or another splitter, a lead extension, an adaptor, or the like).

The implantable control module 402 includes a connector housing 448 anda sealed electronics housing 450. An electronic subassembly 452 (whichincludes the processor 110 (see, FIGS. 1-3) and the power source 414 aredisposed in the electronics housing 450. A connector 445 is disposed inthe connector housing 448. The connector 445 is configured and arrangedto make an electrical connection between the lead 403 and the electronicsubassembly 452 of the implantable control module 402.

The electrical stimulation system or components of the electricalstimulation system, including the paddle body 444, the one or more ofthe lead bodies 446, and the implantable control module 402, aretypically implanted into the body of a patient. The electricalstimulation system can be used for a variety of applications including,but not limited to deep brain stimulation, neural stimulation, spinalcord stimulation, muscle stimulation, and the like.

The electrodes 434 can be formed using any conductive, biocompatiblematerial. Examples of suitable materials include metals, alloys,conductive polymers, conductive carbon, and the like, as well ascombinations thereof. In at least some embodiments, one or more of theelectrodes 434 are formed from one or more of: platinum, platinumiridium, palladium, palladium rhodium, or titanium.

Any suitable number of electrodes 434 can be disposed on the leadincluding, for example, four, five, six, seven, eight, nine, ten,eleven, twelve, fourteen, sixteen, twenty-four, thirty-two, or moreelectrodes 434. In the case of paddle leads, the electrodes 434 can bedisposed on the paddle body 444 in any suitable arrangement. In FIG. 11,the electrodes 434 are arranged into two columns, where each column haseight electrodes 434.

The electrodes of the paddle body 444 (or one or more lead bodies 446)are typically disposed in, or separated by, a non-conductive,biocompatible material such as, for example, silicone, polyurethane,polyetheretherketone (“PEEK”), epoxy, and the like or combinationsthereof. The one or more lead bodies 446 and, if applicable, the paddlebody 444 may be formed in the desired shape by any process including,for example, molding (including injection molding), casting, and thelike. The non-conductive material typically extends from the distal endsof the one or more lead bodies 446 to the proximal end of each of theone or more lead bodies 446.

In the case of paddle leads, the non-conductive material typicallyextends from the paddle body 444 to the proximal end of each of the oneor more lead bodies 446. Additionally, the non-conductive, biocompatiblematerial of the paddle body 444 and the one or more lead bodies 446 maybe the same or different. Moreover, the paddle body 444 and the one ormore lead bodies 446 may be a unitary structure or can be formed as twoseparate structures that are permanently or detachably coupled together.

One or more terminals (e.g., 560 in FIGS. 13A-13B) are typicallydisposed along the proximal end of the one or more lead bodies 446 ofthe electrical stimulation system 400 (as well as any splitters, leadextensions, adaptors, or the like) for electrical connection tocorresponding connector contacts (e.g., 564 in FIGS. 13A-13B). Theconnector contacts are disposed in connectors (e.g., 445 in FIGS.11-13B; and 572 FIG. 13B) which, in turn, are disposed on, for example,the implantable control module 402 (or a lead extension, a splitter, anadaptor, or the like). One or more electrically conductive wires,cables, or the like (i.e., “conductors”—not shown) extend from theterminal(s) to the electrode(s). In at least some embodiments, there isat least one (or exactly one) terminal conductor for each terminal whichextends to at least one (or exactly one) of the electrodes.

The one or more conductors are embedded in the non-conductive materialof the lead body 446 or can be disposed in one or more lumens (notshown) extending along the lead body 446. For example, any of theconductors may extend distally along the lead body 446 from theterminals 560.

FIG. 13A is a schematic side view of one embodiment of a proximal end ofone or more elongated devices 500 configured and arranged for couplingto one embodiment of the connector 445. The one or more elongateddevices may include, for example, one or more of the lead bodies 446 ofFIG. 11, one or more intermediate devices (e.g., a splitter, the leadextension 524 of FIG. 13B, an adaptor, or the like or combinationsthereof), or a combination thereof.

The connector 445 defines at least one port into which a proximal ends446A, 446B of the elongated device 500 can be inserted, as shown bydirectional arrows 562 a, 562 b. In FIG. 13A (and in other figures), theconnector housing 448 is shown having two ports 554 a, 554 b. Theconnector housing 448 can define any suitable number of ports including,for example, one, two, three, four, five, six, seven, eight, or moreports.

The connector 445 also includes one or more connector contacts, such asconnector contact 564, disposed within each port 554 a, 554 b. When theelongated device 500 is inserted into the ports 554 a, 554 b, theconnector contact(s) 564 can be aligned with the terminal(s) 560disposed along the proximal end(s) of the elongated device(s) 500 toelectrically couple the implantable control module 402 to the electrodes(434 of FIG. 11) disposed on the paddle body 445 of the lead 403.Examples of connectors in implantable control modules are found in, forexample, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporatedby reference in their entireties.

FIG. 13B is a schematic side view of another embodiment that includes alead extension 524 that is configured and arranged to couple one or moreelongated devices 500 (e.g., one of the lead bodies 446 of FIGS. 11 and12, the splitter 457 of FIG. 12, an adaptor, another lead extension, orthe like or combinations thereof) to the implantable control module 402.In FIG. 13B, the lead extension 524 is shown coupled to a single port554 defined in the connector 445. Additionally, the lead extension 524is shown configured and arranged to couple to a single elongated device500. In alternate embodiments, the lead extension 524 is configured andarranged to couple to multiple ports 554 defined in the connector 445,or to receive multiple elongated devices 500, or both.

A lead extension connector 572 is disposed on the lead extension 524. InFIG. 13B, the lead extension connector 572 is shown disposed at a distalend 576 of the lead extension 524. The lead extension connector 572includes a connector housing 578.

The connector housing 578 defines at least one port 530 into whichterminal(s) 560 of the elongated device 500 can be inserted, as shown bydirectional arrow 538. The connector housing 578 also includes aplurality of connector contacts, such as connector contact 580. When theelongated device 500 is inserted into the port 530, the connectorcontacts 580 disposed in the connector housing 578 can be aligned withthe terminal(s) 560 of the elongated device 500 to electrically couplethe lead extension 524 to the electrodes (434 of FIGS. 11 and 12)disposed along the lead (403 in FIGS. 11 and 12).

In at least some embodiments, the proximal end of the lead extension 524is similarly configured and arranged as a proximal end of the lead 403(or other elongated device 500). The lead extension 524 may include oneor more electrically conductive wires (not shown) that electricallycouple the connector contact(s) 580 to a proximal end 548 of the leadextension 524 that is opposite to the distal end 576. The conductivewire(s) disposed in the lead extension 524 can be electrically coupledto one or more terminals (not shown) disposed along the proximal end 548of the lead extension 524. The proximal end 548 of the lead extension524 is configured and arranged for insertion into a connector disposedin another lead extension (or another intermediate device). As shown inFIG. 13B, the proximal end 548 of the lead extension 524 is configuredand arranged for insertion into the connector 445.

The embodiments of FIGS. 11-13B illustrate a control module 402 with aconnector 445 into which a proximal end portion of the lead or leadextension can be removably inserted. It will be recognized, however,that other embodiments of a control module and lead can have the lead orlead extension permanently attached to the control module. Such anarrangement can reduce the size of the control module as the conductorsin the lead can be permanently attached to the electronic subassembly.It will also be recognized that, in at least some embodiments, more thanone lead can be attached to a control module.

The above specification and examples provide a description of themanufacture and use of the invention. Since many embodiments of theinvention can be made without departing from the spirit and scope of theinvention, the invention also resides in the claims hereinafterappended.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A system for storing stimulation programs orsets of stimulation parameters, the system comprising: at least onememory; at least one of i) a plurality of stimulation programs or ii) aplurality of sets of stimulation parameters stored on the at least onememory from a plurality of different devices remote from the system andused to stimulate a plurality of different patients; at least oneprocessor coupled to the at least one memory and configured and arrangedto retrieve the stored stimulation programs or sets of stimulationparameters from the at least one memory when requested and to storeadditional stimulation programs or sets of stimulation parameters on theat least one memory; and a communications arrangement coupled to the atleast one processor and configured and arranged to deliver the storedstimulation programs or sets of stimulation parameters to externaldevice and to receive additional stimulation programs and sets ofstimulation parameters from external devices.
 2. The system of claim 1,further comprising lead placement information for at least onestimulation therapy stored on the at least one memory and accessible viathe at least one processor and communications arrangement.
 3. The systemof claim 1, wherein the system is configured and arranged, via the atleast one processor and communications arrangement, to receive a scoreor rating for at least one of the stimulation programs or sets ofstimulation parameters and to store, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters.
 4. The system of claim 3,wherein the system is configured and arranged, via the at least oneprocessor and communications arrangement, to request the score or ratingfor at least one of the stimulation programs or sets of stimulationparameters from a user that has received the one of the stimulationprograms or sets of stimulation parameters.
 5. The system of claim 1,wherein the system is configured and arranged, via the at least oneprocessor and communications arrangement, to receive a review orrecommendation for at least one of the stimulation programs or sets ofstimulation parameters and to store, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters.
 6. The system of claim 1,wherein the at least one processor is configured and arranged to analyzethe stimulation programs or sets of stimulation parameters and, via atleast one machine learning algorithm, generate a new stimulation programor set of stimulation parameters to improve treatment efficacy.
 7. Thesystem of claim 1, wherein the at least one processor is configured andarranged to analyze the stimulation programs or sets of stimulationparameters and, via at least one machine learning algorithm, generate amodified stimulation program or set of stimulation parameters to improvetreatment efficacy.
 8. The system of claim 1, wherein the at least oneprocessor is configured and arranged to analyze the stimulation programsor sets of stimulation parameters and, via at least one machine learningalgorithm, generate a new stimulation program or set of stimulationparameters based on at least one of a patient characteristic; disease ordisorder or condition; symptom or symptoms; stimulation device or leadtype; or electrode or lead location.
 9. The system of claim 1, whereinthe system is configured and arranged to permit a user to purchase atleast one of the stimulation programs or sets of stimulation parametersand to provide, via the at least one processor and communicationsarrangement, the purchased at least one of the stimulation programs orsets of stimulation parameters to the user.
 10. The system of claim 1,wherein the system is configured and arranged to categorize thestimulation programs or sets of stimulation parameters and to permit theuser to access the stimulation programs or sets of stimulationparameters via the categorization.
 11. The system of claim 10, whereinthe categorization is based on at least one of type of disease ordisorder or condition; type of stimulation; area of symptommanifestation; lead or electrode placement; or physical activity type.12. A computer-based method, wherein a plurality of actions areperformed by a processor, the actions comprising: receiving a pluralityof stimulation programs or a plurality of sets of stimulation parametersfrom a plurality of different devices remote from the processor and usedto stimulate a plurality of different patients; storing the plurality ofstimulation programs or plurality of sets of stimulation parameters onat least one memory; and retrieve the stored stimulation programs orsets of stimulation parameters from the at least one memory whenrequested by user.
 13. The computer-based method of claim 12, whereinthe actions further comprise receiving a score or rating for at leastone of the stimulation programs or sets of stimulation parameters andstoring, on the at least one memory, the score or rating in conjunctionwith that at least one of the stimulator programs or sets of stimulationparameters.
 14. The computer-based method of claim 13, wherein theactions further comprise requesting the score or rating for at least oneof the stimulation programs or sets of stimulation parameters from auser that has received the one of the stimulation programs or sets ofstimulation parameters.
 15. The computer-based method of claim 12,wherein the actions further comprise receiving a review orrecommendation for at least one of the stimulation programs or sets ofstimulation parameters and storing, on the at least one memory, thescore or rating in conjunction with that at least one of the stimulatorprograms or sets of stimulation parameters.
 16. The computer-basedmethod of claim 12, wherein the actions further comprise analyzing thestimulation programs or sets of stimulation parameters and, via at leastone machine learning algorithm, generating a new stimulation program orset of stimulation parameters to improve treatment efficacy.
 17. Thecomputer-based method of claim 12, wherein the actions further compriseanalyzing the stimulation programs or sets of stimulation parametersand, via at least one machine learning algorithm, generating a modifiedstimulation program or set of stimulation parameters to improvetreatment efficacy.
 18. The computer-based method of claim 12, whereinthe actions further comprise analyzing the stimulation programs or setsof stimulation parameters and, via at least one machine learningalgorithm, generating a new stimulation program or set of stimulationparameters based on at least one of a patient characteristic; disease ordisorder or condition; symptom or symptoms; stimulation device or leadtype; or electrode or lead location.
 19. The computer-based method ofclaim 12, wherein the actions further comprise permitting a user topurchase at least one of the stimulation programs or sets of stimulationparameters and providing the purchased at least one of the stimulationprograms or sets of stimulation parameters to the user.
 20. Thecomputer-based method of claim 12, wherein the actions further comprisecategorizing the stimulation programs or sets of stimulation parametersand to permit the user to access the stimulation programs or sets ofstimulation parameters via the categorization.